Flourish Vaginal Care System for Neovaginal Microbiome Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sexual Health and Wellness Institute

Disqualifiers: Immunosuppressed, Allergies, Vaginal infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the Flourish Vaginal Care system can help create a healthy vaginal environment for transgender women after gender-confirming surgery. Participants are divided into three groups: transgender women using the Flourish system, transgender women using standard care products, and healthy cisgender women using the Flourish system. The trial aims to determine if the Flourish products can establish a balanced microbiome (the collection of healthy bacteria) in this new environment. Transgender women planning to undergo gender-confirmation surgery and healthy cisgender women may be suitable candidates for this study. As an unphased study, this trial offers participants the chance to contribute to groundbreaking research in transgender health care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Flourish Vaginal Care System is safe for neovaginal microbiome health?

Research shows that the Flourish Vaginal Care system is designed to maintain vaginal health. This commercially available product is often used for vaginal care. Although specific safety data for transgender women is limited, it is generally well-tolerated in similar contexts.

In studies with cisgender women, the Flourish system has been used without major safety concerns. The treatment includes external washes, moisturizing gels, and probiotics, which are common in vaginal care and generally safe when used as directed.

Since the trial does not test new treatments, the product is not experimental and is likely considered safe based on previous use. However, prospective participants should consult their healthcare provider to ensure it is appropriate for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Flourish Vaginal Care System because it offers a comprehensive approach to enhancing neovaginal microbiome health, especially following gender-confirming surgery. Unlike traditional options like KY jelly or standard hygiene products, Flourish incorporates a unique combination of a probiotic suppository, a moisturizing gel, and an external wash specifically designed for vaginal care. This system aims to support healing and maintain a healthy microbiome through targeted use of probiotics and hydrating agents, potentially offering more tailored and effective care for transgender women post-surgery.

What evidence suggests that the Flourish Vaginal Care System is effective for neovaginal microbiome health?

Research shows that the Flourish Vaginal Care system may help create a healthy balance of good bacteria in transgender women who have undergone gender-confirming surgery. In this trial, one group of transgender women will use the Flourish system, which includes an external wash, moisturizing gel, and probiotic suppository, all designed to support a healthy bacterial balance. Another group of transgender women will not use the Flourish system, serving as a comparison. Studies have found that the bacteria in the neovagina of transgender women can resemble those found in bacterial vaginosis, an imbalance of bacteria. For cisgender women, who are also part of this trial, Flourish has been shown to lower vaginal pH, indicating a healthier environment, and reduce symptoms like pain and itching. These findings suggest that the Flourish system could help create a more balanced and comfortable vaginal environment. ^{1 3 6 7 8}

Who Is on the Research Team?

Christine McGinn, DO

Principal Investigator

Papillon Center

Are You a Good Fit for This Trial?

This trial is for healthy cisgender women aged 18-52 and transgender women over age 18 who are planning to have gender-confirmation surgery. Participants should not be allergic to aloe vera or components of the Flourish Vaginal Care system, nor have certain infections or immune suppression.

Exclusion Criteria

My immune system is weakened.

I have a vaginal infection that is not yeast or BV.

I cannot tolerate Restore gel after my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Flourish Vaginal Care System or standard care for 6 months to establish a neovaginal microbiome

6 months

Collections at time 0, 6 weeks, and 6 months

Follow-up

Participants are monitored for changes in vaginal pH and microbiome composition after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flourish Vaginal Care system

Trial Overview The study is testing the Flourish Vaginal Care System's ability to establish a healthy microbiome in neovaginas of transgender women post-surgery, using commercially-available wellness products.

How Is the Trial Designed?

Group I: Group 3: Cisgender women Experimental Treatment 1 Intervention

This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study.

Group II: Group 1: Transgender women using Flourish Experimental Treatment 1 Intervention

After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months.

Group III: Group 2: Transgender women not using Flourish Active Control 1 Intervention

After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months.

Who Is Running the Clinical Trial?

Sexual Health and Wellness Institute

Lead Sponsor

Trials

9

Recruited

170+

Vaginal Biome Science

Lead Sponsor

Trials

10

Recruited

3,400+

Papillon Center

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

In a pilot study involving 43 healthy premenopausal women, a 10-strain probiotic formulation significantly reduced vaginal pH, indicating potential benefits for vaginal health, particularly in those with intermediate Nugent scores or elevated pH levels.

The probiotic was well tolerated with high compliance, and while it did not significantly change Nugent scores, it maintained lactobacilli abundance, suggesting a positive impact on vaginal microbiota.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 10-Strain Oral Probiotic on Parameters of Vaginal Health and Microbial Community: A Pilot Clinical Study. Martoni, CJ., Frederiksen, AKS., Damholt, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05701722

Effect of Flourish HEC Vaginal Care System on BV ... A 2019 meta-analysis found that vaginal probiotics for BV are safe and effective, though the authors noted a need for studies with larger numbers of women.

2. journals.lww.com journals.lww.com/greenjournal/abstract/2022/05001/preliminary_data_from_clinical_trial_to_survey.80.aspx

Preliminary Data from Clinical Trial to Survey Results of... Mean vaginal pH decreased from 4.54 to 4.08 at baseline to study end. Journals showed decreased frequencies of pain and irritation (∼2-fold) and itching (∼4- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05372770?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(Papillon))&rank=6

Flourish Vaginal Care System to Establish Neovaginal ... This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8058480/

The Female Vaginal Microbiome in Health and Bacterial ... This review covers the features of vaginal microbiome, BV, BV-associated diseases, and various strategies of diagnosis and treatment of BV

5. nature.com nature.com/articles/s41522-022-00295-y

The right bug in the right place: opportunities for bacterial ... Sexual Health and Wellness Institute. Clinical Trial to Survey Results of Flourish Vaginal Care System for Recurrent Bacterial Vaginosis.

6. ctv.veeva.com ctv.veeva.com/study/flourish-vaginal-care-system-to-establish-neovaginal-microbiome

Flourish Vaginal Care System to Establish Neovaginal ... This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7201977/

The neovaginal microbiome of transgender women post ... There are scarce data about the environment of the neovagina particularly at the molecular and microbial level. For cisgender women (CW), i.e., ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39109262/

The Vaginal Microbiome of Transgender and Gender ... The goal of this preliminary study is to describe the vaginal microbiome of transgender and gender nonbinary (TGNB) individuals using nonculture-based ...